SOP for Operation Of Sampling Booth

Standard Operating Procedure for operation of the sampling booth to avoid the cross contamination.

1.0 Purpose

The purpose of this SOP is to develop a standard procedure for operation of the sampling booth to prevent airborne material contamination during the sampling process.

2.0 Scope

This SOP is applicable for the sampling booths installed in the pharmaceutical industry.

3.0 Responsibility

3.1 Quality control lab assistant is responsible for performing sampling activity.

Raw material store officer is responsible for supervising the sampling activity.

3.2 The HOP is responsible for ensuring the implementation of the current SOP.

3.3 Q.A. Officer monitors the compliance of this SOP.

4.0 Procedure

4.1 Ensure that the sampling booth is cleaned before performing the sampling activity to prevent contamination or cross contamination.

4.2 Press ON button to turn ON the main HMI of the sampling booth.

4.3 Turn the lights On by pressing the ON button.

4.4 Turn the blower ON & keep it running for about 1 hour before sampling.

4.5 Record the reading of differential pressure & it must be within range as per the SOP.

4.6 If differential pressure readings are not as per SOP then check/clean or replace the filters installed for air filtration.

4.7 Check the temperature & humidity inside the booth & if differential pressure, temperature & RH are as per requirement then take the line clearance for sampling from QA.

4.8 After line clearance open the material container & sample it as per the sampling SOP by using a cleaned sampling device.

4.9 Sample one material at a time & for product change clean the sampling booth & sampling device as per cleaning SOP of sampling booth.

4.10 Take sampled material in cleaned sample boxe & close the container properly to bring it back.

5.0 Abbreviations

5.1 SOP: Standard Operating Procedure

5.2 QA: Quality Assurance

5.3 HOP:Head Of Production.


Sampling booths are designed in such a way that fresh air is taken up by the blower which passes through the core filter then 5 micron filter & finally through the HEPA filter to provide a clean environment inside the sampling booth.

Also, Read

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